A Study of the Effect of Lenalidamide on Complex Regional Pain Syndrome Type 1

This study has been completed.
Sponsor:
Collaborator:
Elgene Chemical
Information provided by:
Mayo Clinic
ClinicalTrials.gov Identifier:
NCT00166452
First received: September 12, 2005
Last updated: March 22, 2011
Last verified: March 2011
  Purpose

The purpose of this study is to determine if lenalidomide is a safe and effective treatment for complex regional pain syndrome type 1 (CRPS).


Condition Intervention Phase
Complex Regional Pain Syndrome, Type 1
Drug: Lenalidamide
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Multicenter, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Lenalidamide in the Treatment of Complex Regional Pain Syndrome Type1

Resource links provided by NLM:


Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • RPS Pain Intensity Numeric Rating Scale (PI-NRS): At least 30% reduction from baseline

Enrollment: 7
Study Start Date: July 2005
Study Completion Date: February 2009
Primary Completion Date: April 2007 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age > or = to 18 years
  2. Signed consent form
  3. A diagnosis of CRPS type I for at least one-year duration with unilateral involvement of a distal limb
  4. CRPS pain intensity score at least 4 on an 11-point PI-NRS
  5. Measurable sural, median sensory, median motor and peroneal motor nerve conductions
  6. Women of childbearing potential must have a negative serum or urine pregnancy test within 7 days of starting the study drug. They must agree to use adequate contraceptive methods not including steroid-based contraceptives. They must also agree to have pregnancy tests every 4 weeks while on the study drug.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00166452

Locations
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Elgene Chemical
Investigators
Principal Investigator: Keith A Bengtson, M.D. Mayo Clinic
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00166452     History of Changes
Other Study ID Numbers: 422-05
Study First Received: September 12, 2005
Last Updated: March 22, 2011
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Somatoform Disorders
Complex Regional Pain Syndromes
Mental Disorders
Autonomic Nervous System Diseases
Nervous System Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases

ClinicalTrials.gov processed this record on August 21, 2014